The usefulness and Safety of propofol for benzodiazepine resistance cases in endoscopic sedation

Acronym

Propofol for benzodiazepine resistance cases in endoscopic sedation

Scientific Title

The usefulness and Safety of propofol for benzodiazepine resistance cases in endoscopic sedation

Scientific Title:Acronym

Propofol for benzodiazepine resistance cases in endoscopic sedation

Region

Japan

Condition

Condition

Disease that requires endoscopic procedures

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Objectives

Narrative objectives1

In performing an endoscopic procedure, to evaluate the usefulness and safety of propofol for the patient of benzodiazepine derivatives resistance in case of sedation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Adverse events and safety in using propofol

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

We use propofol, if midazolam is insufficient in sedation.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Endoscopy procedures that required sedation.
2.More than 20 years of age.
3.ECOG Performance Status is 0 or 1.
4.There is no severe liver or kidney dysfunction.
5.No contraindication for propofol.
6.Have been obtained the consent of the study participants in the document.

Key exclusion criteria

1. Hypersensitivity history to propofol or formulation.
2. During pregnancy, during lactation.
3. ECOG-Performance Status is over 2 or more.
4. Advanced liver of kidney dysfunction.
5. Determined to be inappropriate to carry out the study.